Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US
RICHARD WOLF MEDICAL INSTRUMENTS CORP. appears in FDA device records in Vernon Hills, IL. FDA records list 153 510(k) clearances between and , 4 PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Richard Wolf Medical Instruments Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Richard Wolf Medical Instrument Corprecall
510(k) clearance history
Showing 50 of 153FDA records hold 153 510(k) clearances for Richard Wolf Medical Instruments Corp. between 1977 and 2024. The busiest year on record is 1994, with 22. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 12 |
| 1979 | 1 |
| 1980 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 2 |
| 1994 | 22 |
| 1995 | 8 |
| 1996 | 7 |
| 1997 | 19 |
| 1998 | 13 |
| 1999 | 11 |
| 2000 | 5 |
| 2001 | 9 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 3 |
| 2005 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231291 | Perforated Baskets | KCT | Substantially Equivalent | |
| K230194 | HF Surgery Generator 400KHZ | GEI | Substantially Equivalent | |
| K212808 | Logic Hd camera head green, System green | FET | Substantially Equivalent | |
| K211332 | D Camera Controller | FET | Substantially Equivalent | |
| K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM | GCM | Substantially Equivalent | |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | FGB | Substantially Equivalent | |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | FET | Substantially Equivalent | |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | FGB | Substantially Equivalent | |
| K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | FET | Substantially Equivalent | |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | GEI | Substantially Equivalent | |
| K161204 | ENDOCAM Flex HD Camera System 5521 | FET | Substantially Equivalent | |
| K151282 | core nova Complete Operating Room Endoscopy | ODA | Substantially Equivalent | |
| K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | FET | Substantially Equivalent | |
| K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | FCW | Substantially Equivalent | |
| K120898 | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA | OTJ | Substantially Equivalent | |
| K090776 | MEGAPULSE LASER SYSTEM AND FIBERS | GEX | Substantially Equivalent | |
| K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES | HRX | Substantially Equivalent | |
| K080977 | 3 CCD ENDOCAM 5550 | GCJ | Substantially Equivalent | |
| K071292 | VIEW MD OFFICE SYSTEM, MODEL 41066.5540 | GCJ | Substantially Equivalent | |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | FJL | Substantially Equivalent | |
| K051276 | HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM | OCZ | Substantially Equivalent | |
| K051176 | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 | FAJ | Substantially Equivalent | |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | FJL | Substantially Equivalent | |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | FJL | Substantially Equivalent | |
| K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES | GWG | Substantially Equivalent | |
| K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | HET | Substantially Equivalent | |
| K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 | HIH | Substantially Equivalent | |
| K030082 | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 | HRX | Substantially Equivalent | |
| K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 | GWG | Substantially Equivalent | |
| K023659 | 1-CCD ENDOCAM 5520 SYSTEM | FET | Substantially Equivalent | |
| K023813 | BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 | ODA | Substantially Equivalent | |
| K010033 | LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 | GCJ | Substantially Equivalent | |
| K012309 | RIWO SYSTEM TRAYS | FEB | Substantially Equivalent | |
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | FFK | Substantially Equivalent | |
| K002328 | SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR | HIF | Substantially Equivalent | |
| K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | FBO | Substantially Equivalent | |
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) | FFK | Substantially Equivalent | |
| K002000 | MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; | GEI | Substantially Equivalent | |
| K003417 | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET | HET | Substantially Equivalent | |
| K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP | HIF | Substantially Equivalent | |
| K003164 | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM | HET | Substantially Equivalent | |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | FGA | Substantially Equivalent | |
| K000673 | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 | HIH | Substantially Equivalent | |
| K000905 | URETHROTOME 8667.XXX AND 8670.XXX | EZO | Substantially Equivalent | |
| K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) | HRX | Substantially Equivalent | |
| K994363 | INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) | HRX | Substantially Equivalent | |
| K993103 | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES | GCM | Substantially Equivalent | |
| K991906 | LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT | HIF | Substantially Equivalent | |
| K990397 | FLEXIBLE FIBERSCOPES & ACCESSORIES | HRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1418479 | 1418479 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 353 CORPORATE WOODS PKWY., VERNON HILLS, IL 60061 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- FEBAccessories, Cleaning, For Endoscope
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- HRXArthroscope
- FWGCamera, Television, Endoscopic, With Audio
- FWFCamera, Television, Endoscopic, Without Audio
- FBNCholedochoscope And Accessories, Flexible/Rigid
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- HEXColposcope (And Colpomicroscope)
- HEWCuldoscope (And Accessories)
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- EZNDilator, Catheter, Ureteral
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HDPElevator, Uterine
- GWGEndoscope, Neurological
- GCMEndoscope, Rigid
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- HIHHysteroscope (And Accessories)
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- FGAKit, Nephroscope
- HTSKnife, Orthopedic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- KNHLaparoscopic Contraceptive Tubal Occlusion Device
- FDELaparoscopy Kit
- EQLLaryngostroboscope
- LLOLaser, Neodymium:Yag, Pulmonary Surgery
- HHRLaser, Surgical, Gynecologic
- NTNLed Light Source
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- FFKLithotriptor, Electro-Hydraulic
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological
- FEOLithotriptor, Ultrasonic
- ISAMassager, Therapeutic, Electric
- KITMedia And Components, Synthetic Cell And Tissue Culture
- EWYMediastinoscope, Surgical
- EOBNasopharyngoscope (Flexible Or Rigid)
- LXHOrthopedic Manual Surgical Instrument
- GEXPowered Laser Surgical Instrument
- FJLResectoscope
- FDCResectoscope, Working Element
- HRRScissors, Orthopedic, Surgical
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- KYZSyringe, Irrigating (Non Dental)
- FBPTelescope, Rigid, Endoscopic
- ECBUnit, Syringe, Air And/Or Water
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1957-2019 | E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology. | E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. | Class II | Terminated | |
| Z-2608-2016 | Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes. | The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients. | Class II | Terminated | |
| Z-1188-2016 | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures. | Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting. | Class II | Terminated | |
| Z-0791-2016 | Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. | Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. | Class II | Terminated | |
| Z-0790-2016 | Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. | Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. | Class II | Terminated | |
| Z-0789-2016 | Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. | Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. | Class II | Terminated | |
| Z-1240-2015 | The I-Cart is used to store, transport, and power video equipment used in medical procedures. | The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis. | Class II | Terminated | |
| Z-0037-2015 | The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. | Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232. | Class II | Terminated | |
| Z-0145-2014 | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary. | Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. | Class II | Terminated | |
| Z-0272-2010 | Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes | The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile. | Terminated | ||
| Z-1430-06 | Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801 | The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed. | Terminated | ||
| Z-0537-04 | Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany | If the drain tube is assembled incorrectly, the suction pump will not operate as intended. | Terminated | ||
| Z-0081-04 | Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061 | The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain